Effect of the machine learning-derived Hypotension Prediction Index (HPI) combined with diagnostic guidance versus standard care on depth and duration of intraoperative and postoperative hypotension in elective cardiac surgery patients: HYPE-2 - study protocol of a randomised clinical trial.

Hypotension is common during cardiac surgery and often persists postoperatively in the intensive care unit (ICU). Still, treatment is mainly reactive, causing a delay in its management. The Hypotension Prediction Index (HPI) can predict hypotension with high accuracy. Using the HPI combined with a guidance protocol resulted in a significant reduction in the severity of hypotension in four non-cardiac surgery trials. This randomised trial aims to evaluate the effectiveness of the HPI in combination with a diagnostic guidance protocol on reducing the occurrence and severity of hypotension during coronary artery bypass grafting (CABG) surgery and subsequent ICU admission. This is a single-centre, randomised clinical trial in adult patients undergoing elective on-pump CABG surgery with a target mean arterial pressure of 65 mm Hg. One hundred and thirty patients will be randomly allocated in a 1:1 ratio to either the intervention or control group. In both groups, a HemoSphere patient monitor with embedded HPI software will be connected to the arterial line. In the intervention group, HPI values of 75 or above will initiate the diagnostic guidance protocol, both intraoperatively and postoperatively in the ICU during mechanical ventilation. In the control group, the HemoSphere patient monitor will be covered and silenced. The primary outcome is the time-weighted average of hypotension during the combined study phases. The medical research ethics committee and the institutional review board of the Amsterdam UMC, location AMC, the Netherlands, approved the trial protocol (NL76236.018.21). No publication restrictions apply, and the study results will be disseminated through a peer-reviewed journal. The Netherlands Trial Register (NL9449), ClinicalTrials.gov (NCT05821647).

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Déclaration de conflit d'intérêts

Competing interests: The Departments of Anaesthesiology and Intensive Care of the Amsterdam UMC, location AMC, receive financial support from Edwards Lifesciences to perform this study. Alexander P.J. Vlaar reports receipt of unrestricted research grants and lecture fees from Edwards Lifesciences and Philips paid to the institution. Denise P. Veelo reports receipt of research grants from Philips as well as consultancy, lecture, and travel expenses fees from Edwards Lifesciences. Bart F. Geerts reports receipt of research grants from Edwards Lifesciences and Philips and additional consultancy fees from Philips. Finally, Markus Hollmann reports receipt of a research grant from the Dutch healthcare financing organization ZonMW paid to the institution, consulting fees from Commonwealth Serum Laboratories (CSL) Behring and Interventional Drug Development (IDD) Pharma, and he serves as an executive section editor for Anesthesia Analgesia, section editor for Journal of Clinical Medicine, and editor for Frontiers in Physiology. The other authors have no conflicts of interest to declare.